NCT03770169

Brief Summary

The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

November 29, 2018

Last Update Submit

October 25, 2019

Conditions

Vulvodynia

Outcome Measures

Primary Outcomes (3)

  • Validation of mVPAQ

    Cognitive debrief and usability through interviews and completion of an electronic diary

    1 week

  • Validation of mFSFI

    Cognitive debrief and usability through interviews and completion of an electronic diary

    1 week

  • Validation of Pain on Intercourse Numeric Rating Scale (NRS)

    Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.

    1 week

Secondary Outcomes (1)

  • Vulvar pain NRS

    1 week

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred by clinicians

You may qualify if:

  • Fluent in understanding, speaking and reading US-English
  • Have vulvodynia with pain for at least 6 months

You may not qualify if:

  • Clinically significant history of alcohol/drug abuse or dependence within the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Center for Vulvovaginal Disorders

Washington D.C., District of Columbia, 20037, United States

Location

Omaha OB-GYN Associates, PC

Omaha, Nebraska, 68130, United States

Location

The Center for Vulvovaginal Disorders

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 10, 2018

Study Start

February 18, 2019

Primary Completion

September 19, 2019

Study Completion

September 19, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10

Locations

US(4)